Ankle InjuriesNCT00541580
Comparative Results of Conservatively and Surgically Treated Adolescents With Triplane and Juvenile Tillaux Ankle Fractures After Skeletal Maturity
An observational study of Ankle Injuries, run by Hadassah Medical Organization.
Trial summary
Triplane and Juvenile Tillaux fractures of the ankle are well known in adolescent pediatric population. It is widely accepted, that optimal treatment for displaced fractures is close or open reduction and fixation with screws under general anesthesia and under intraoperative fluoroscopy control. Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Ankle Injuries
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- Adult
Study population: adolescents with triplane and juvenile Tillaux ankle fractures
Who may be able to join
- Sign informed consent.
Who cannot join
- Pregnancy
- Unwillingness to sign the informed consent.
About this study
Triplane and Juvenile Tillaux fractures of the ankle are well known in adolescent pediatric population. It is widely accepted, that optimal treatment for displaced fractures is close or open reduction and fixation with screws under general anesthesia and under intraoperative fluoroscopy control. Usually a small degree of displacement (up to 2mm) is expected to be healed without any sequences. Until now, no evidence of ankle function and pain after skeletal maturity or long follow-up was published. More than that, no comparative study between operative and no operative treatment of mild and borderline displaced fractures were published.
The purpose of this study is to evaluate functional and radiographic results of operatively and conservatively treated patients after they reach skeletal maturity.
- Conditions
- Ankle Injuries
- Medical subject headings
- Ankle Injuries
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle InjuriesStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Investigators
- Vladimir Goldman, MD, Principal investigator, Hadassah Medical OrganizationNeum Simanovsky, MD, Study director, Hadassah Medical OrganizationNatalia Simanovski, MD, Study chair, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00541580
- Sponsor's protocol ID
- GOLD-001-HMO-CTIL
- Status last verified
- Sep 2011
- First submitted
- 7 Oct 2007
- Last updated
- 16 Sep 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Results of Conservatively and Surgically Treated Adolescents With Triplane and Juvenile Tillaux Ankle Fractures After Skeletal Maturity
- ClinicalTrials.gov ID
- NCT00541580
- Acronym / sponsor ID
- GOLD-001-HMO-CTIL
- Conditions
- Ankle Injuries
- Study type
- Observational
- Recruitment status
- Terminated
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- First posted
- 10 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Triplane and Juvenile Tillaux fractures of the ankle are well known in adolescent pediatric population. It is widely accepted, that optimal treatment for displaced fractures is close or open reduction and fixation with screws under general anesthesia and under intraoperative fluoroscopy control. Usually a small degree of displacement (up to 2mm) is expected to be healed without any sequences. Until now, no evidence of ankle function and pain after skeletal maturity or long follow-up was published. More than that, no comparative study between operative and no operative treatment of mild and borderline displaced fractures were published.
The purpose of this study is to evaluate functional and radiographic results of operatively and conservatively treated patients after they reach skeletal maturity.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Age groups
- Adult
- Study population
- adolescents with triplane and juvenile Tillaux ankle fractures
Key inclusion criteria (1 listed)
- Sign informed consent.
Key exclusion criteria (2 listed)
- Pregnancy
- Unwillingness to sign the informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vladimir Goldman, MD principal investigator
Hadassah Medical Organization
Neum Simanovsky, MD study director
Hadassah Medical Organization
Natalia Simanovski, MD study chair
Hadassah Medical Organization
Questions about this trial
What is this clinical trial studying?
An observational study of Ankle Injuries, run by Hadassah Medical Organization.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2011.